Method and System for Pay-Per-Use Prescription Validation

ABSTRACT

A business model for facilitating the deployment of prescription validation systems into pharmacies is installed in pharmacies for little or no up-front cost to the pharmacy. Instead, the pharmacy is charged on a per use basis, that is, charged every time a prescription is validated in the system. In this way, the system vendor obtains payment on a subscription-like basis. Up-front costs at the pharmacy are avoided. Moreover, risks to a pharmacy concerning maintenance and slow productivity are avoided, or shifted onto the system owner, who is able to assess those risks.

BACKGROUND OF THE INVENTION

Improperly filled prescriptions represent a substantial risk of injuryto customers at pharmacies. Filling prescriptions is a generallycommoditized business where the objective is to maximize the number ofprescriptions filled by each pharmacist per hour. It is inevitable thatsome prescriptions are filled with the incorrect drugs or medication.

To address this problem, systems for the validation of prescriptionshave been proposed. For example, U.S. Pat. No. 6,771,369 concerns asystem and method for pharmacy validation and inspection. The disclosedsystem provides a combination of a bar code reader and a spectroscopysystem. In operation, a container of pills is provided with a labelcontaining prescription information for a specific patient. The label isread by the system's bar code reader. Contemporaneously, the spectralresponse of the pills contained within the container is also resolved. Adata analysis system then compares the information from the bar codereader with the spectral response information to ensure that thechemical content of the pills within the container matches theprescription. Such systems provide a way of confirming the accuracy of afilled prescription. Specifically, they insure that the contents of thecontainer match the container's label. In this way, errors inprescriptions could be reduced.

SUMMARY OF THE INVENTION

The main impediment to the market penetration of prescription validationsystems into the typical pharmacy is the cost of such systems. Whilethere might be savings in terms of the pharmacy's liability insurancebecause of the decrease in the pharmacy's errors, the systems arecomparatively expensive and represent an up-front cost to the typicalpharmacy. Further, it is often unclear whether such systems will workaccurately enough and at the speeds required in the pharmacy to justifyinvestment. There are also risks to the pharmacy concerning costs ofownership including maintenance and equipment downtime.

The present invention is directed to a business model for facilitatingthe deployment of prescription validation systems into pharmacies.Specifically, these systems are installed in pharmacies for little or noup-front cost to the pharmacy. Instead, the pharmacy is charged on a peruse basis, i.e., charged every time a prescription is validated in thesystem or based on entirely or in part on the number of validationsperformed. In this way, the system vendor obtains payment on asubscription basis. At the same time, up-front costs at the pharmacy areavoided. Moreover, risks to a pharmacy concerning maintenance and slowproductivity are avoided, or shifted onto the system owner, who is ableto assess those risks.

Payment per validation business model is similar to other businessmodels used in the pharmacy industry. For example, currently, a processof “adjudication” is used whereby a pharmacist confirms the level ofinsurance of a given customer. Specifically, when a customer seeks tofill a prescription, the pharmacist will usually contact an insuranceinformation clearing house, which provides the pharmacist withinformation concerning the level of coverage for that specific customer.In this way, the pharmacy can handle prescriptions from customers havingdifferent insurance and different coverage levels, while being assuredthat the insurance company will provide the expected level ofreimbursement.

The above and other features of the invention including various noveldetails of construction and combinations of parts, and other advantages,will now be more particularly described with reference to theaccompanying drawings and pointed out in the claims. It will beunderstood that the particular method and device embodying the inventionare shown by way of illustration and not as a limitation of theinvention. The principles and features of this invention may be employedin various and numerous embodiments without departing from the scope ofthe invention.

BRIEF DESCRIPTION OF THE DRAWINGS

In the accompanying drawings, reference characters refer to the sameparts throughout the different views. The drawings are not necessarilyto scale; emphasis has instead been placed upon illustrating theprinciples of the invention. Of the drawings:

FIG. 1 is a schematic diagram of a prescription validation system usedin the present invention; and

FIG. 2 is a flow diagram illustrating a method for prescriptionvalidation and charges to a pharmacy.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 shows a prescription validation system that is used in connectionwith the present invention, in one example.

The validation system 100 is used to analyze the contents of acontainer, such as a pill container 50. Specifically, in operation, acontainer 50, typically representing a filled prescription, with aprescription specific label 52 on its outer surface, is placed within ananalysis area 110 of the validation system 100.

In one embodiment, both a spectrometer 114 and vision system 116 areoriented to view the contents of the container 50, usually near itsmouth 54. The vision system 116 is used to check the shape, color, andsymbols found on pills, for example, within the container 50. Thespectrometer 114 is used to collect the spectroscopic response of thosesame drugs, such as pills, within the container 50.

Simultaneously or contemporaneously, in one embodiment, a label reader112 reads the prescription information found on the label 52. In oneexample, the label reader has an optical character recognition (OCR)system to decode the human-readable information encoded on the label 52.In another example, the label reader alternatively, or in addition,comprises a machine code reading component such as a bar code readerthat reads a machine-readable, e.g., bar code, found on the label 52.

The prescription information from the label reader 112, thespectroscopic information from the spectrometer 114, and the pill shape,color, and symbol information from the vision system 116 are analyzed bythe prescription validation system controller 120. The controller 120confirms whether the prescription has been properly filled.Specifically, the prescription information found on the label 52 iscompared to the pill shape, color, and/or symbols that were determinedby the vision system 116 and the composition of those pills asdetermined by the spectrometer 114.

According to the invention, the prescription validation systemcontroller 120 connects to a pharmacy management system 130. Thiscontains the pharmacy's database for the drugs and/or drugs held by thepharmacy and/or the existing customers serviced by the pharmacy. Theprescription validation system controller 120 confirms the prescriptioninformation on the label 52 is consistent with this back office system,for example, based on scheduled prescriptions to be filled at thepharmacy. That is, in one embodiment, the pharmacy management systemcomprises customer information and pending prescriptions to be filled.These prescription orders are then assigned to pharmacists at eachvalidation system 100. As prescriptions are validated, the pharmacymanagement system 130 updates the queue of prescriptions to be filledand confirms the validated prescriptions were to be filled.

The prescription validation system controller 120 is also connected to adrug information center database 140. In one example, connection is adata connection across a public network, such as the internet. In otherexamples, the connection is supported by a dial-up connection or otherdirect point-to-point data communication. This drug information centerincludes databases of spectroscopic pill information and pill shape,color and symbol information.

FIG. 2 shows the method of operation for the present invention.

As is common, in step 210, a prescription is received and entered intothe billing/back office pharmacy management system 130 of the pharmacy.Most pharmacies have such a database system that stores previousprescriptions by a patient, the number of refills left on thoseprescriptions, insurance information for patients, billing information,and other account information. The system also controls pharmacyworkflow in some examples so that prescriptions to be filled aredistributed among the working pharmacists.

Then, the billing/back office pharmacy management system 130 contacts aninsurance coverage clearing house. This step is often referred to asadjudication where the pharmacy determines whether the patient iscovered, the insurance company, and the level of coverage to determinethe level of reimbursement that the pharmacy will be receive from thecustomers' insurance.

Then in step 214, the drug is dispensed. Often, this filling isperformed manually by pharmacist who puts a prescribed number of pills,for example, into the container 50. In step 216, pharmacist affixes thelabel 52 to the container 50. Often this label 52 is printed directly bythe billing/back office system 130 for the pharmacy.

In other examples, the steps of filling the container and/or printingand affixing the prescription label 52 to the container 50 are performedby an automated system. Especially in large pharmacies, there aremachines that take entered prescription information and thenautomatically dispense the drugs into the containers 50, including therequired labels 52. In step 218, the container 50 is placed in theanalysis area 110 (see FIG. 1).

In step 220, the validation system 100 acquires a spectroscopic data ofthe drug. Specifically the spectrometer 114 determines the spectralresponse of the pills contained in the container 50.

In step 222, the validation system 100 also preferably acquires imageinformation for the pills using the vision system 116. Preferably thisimage recognition information includes the shape, color and any symbolscontained on the pills.

Based on the spectroscopic and image information, the validation systemcontroller 120 searches for a match in an internal database 122 in step224. The system then determines whether or not there is a match for thepills based on the color, shape, symbols on the pills and/or thespectroscopic data on the pills in step 226. If no match is found, thenin step 228, the validation system sends the spectroscopic, shape, colordata, to the drug information center 140.

In step 230 the drug information center 140 receives this spectroscopicand/or image recognition information from the validation system in step230. It searches in the center's database for a match. The drug center140 then sends match information to the validation system 100 in step232 or signals an error condition with no match being found.

In the event of a non-match at the center's database, the center 140signals for a recalibration of the validation system 100, usuallyincluding a recalibration of the spectroscopy system 114.

Based upon the match information from the drug center 140 or determinedinternally by reference to the database 122 of the validation systemcontroller 120, in step 224, the validation system 100 reads the label52 and/or receives intended prescription information from thebilling/back office system 130. Specifically, the validation system 100or management system 130 validates that a request for this prescriptionexists, that the drugs in the container match both the label 52 on thecontainer 50 and the intended prescription in the back office system130.

Then in step 236, the validation system 100 notifies the pharmacist of amatch or an invalid condition. That is, if there is a detected error inthe data, the system signals that the particular prescription has notbeen properly filled.

In step 238, the drug center 140 also sends an update with thespectroscopic, shape, and color symbol data for the internal database122 of the validation system controller 120. Specifically, the drugcenter 140 updates the internal database 122, in one embodiment, of thevalidation system controller 120 based upon the requests that thevalidation sent in 228. In this way, the validation system controllerwill signal a match if a similar drug is presented to the validationsystem in the future. In step 240, the validation system controller 120then updates its internal database 122 with the new spectroscopic,shape, color and symbol data from the drug center 140.

According to the step 242, the validation system controller 120 notifiesthe drug information center 140 of the validation. In step 224, the druginformation center updates the pharmacy's billing information with thisvalidation. In one embodiment, the center 140 periodically sends a billto the pharmacy. The charges are based on the number of validations thatwere performed over the billing period. In other examples the bill alsoincludes rental or lease changes for the validation system 100 for thebilling period.

Often, the validations will cost only a few cents. Also, in oneembodiment, the pharmacy system notifies the center with accuracyinformation concerning the accuracy with which prescriptions are beingfilled at the pharmacy and any errors originating from the validationsystem 100 in step 246.

In step 248, the drug center further updates its record information withthis information from the local validation system at their pharmacy.

In step 250, the drug information center 140 periodically sends generalupdates for the internal database of the validation system. Theseinternal updates are used, in one embodiment, to increase theprobability of a match when the validation system 100 interrogates itsinternal database. For example, as the composition of pills,specifically pill coatings change, and/or with changes in color andintroduction of instruction of new and generic pills, this informationis continually sent by the drug information center 140 to update theinternal database 122 of each validation system 100 at each pharmacy.Then, finally, in step 252, the pharmacy validation system updates itsinternal database with the new data for its validation system.

While this invention has been particularly shown and described withreferences to preferred embodiments thereof, it will be understood bythose skilled in the art that various changes in form and details may bemade therein without departing from the scope of the inventionencompassed by the appended claims.

1. A method for prescription validation, comprising: a pharmacyvalidation system for performing validations by determining whetherlabels for containers correspond to contents of the containers; thevalidation system sending information that the validation was made to aninformation center; and the information center billing the pharmacybased on a number of validations performed by the validation system. 2.A method as claimed in claim 1, wherein the pharmacy validation systemcomprises: a label reader for reading information encoded on the label.3. A method as claimed in claim 2, wherein the pharmacy validationsystem further comprises at least one of a machine recognition systemfor determining a shape of, color of, and/or symbols on contents of thecontainer and a spectroscopy system for determining a spectral responseof the contents of the container, wherein the step of validating theprescription comprises comparing information from the machinerecognition system and the spectroscopy system to information on thelabels.
 4. A method as claimed in claim 1, wherein the step of thevalidation system sending information that the validation was madecomprises the validation system informing the information center wheneach validation is made.
 5. A method as claimed in claim 1, wherein thestep of the validation system sending information that the validationwas made comprises the validation system periodically informing theinformation center information as to a number of validations made over atime period.
 6. A method as claimed in claim 1, wherein the step of theinformation center billing the pharmacy comprises the information centerperiodically sending a bill based at least in part on a number ofvalidations performed over a period by the validation system of thepharmacy.
 7. A method as claimed in claim 1, wherein the step of theinformation center billing the pharmacy comprises the information centerperiodically sending a bill based in part on a number of validationsperformed over a period by the validation system of the pharmacy and inpart based on rental or lease amount for the period.
 8. A method asclaimed in claim 1, further comprising an information centerperiodically updating an internal database of the validation system withspectroscopy information for drugs dispensed by the pharmacy.
 9. Amethod as claimed in claim 1, further comprising the validation systemconfirming that information from the validations correspond toprescriptions to be filled by a pharmacy by reference to a pharmacymanagement system.
 10. A method for prescription validation, comprising:a pharmacy validation system for analyzing contents of prescriptioncontainers by acquiring information from the contents; the validationsystem searching for a match for the contents of containers in aninternal database and sending the information, including a spectroscopicresponse of the contents, to a drug information center if no match isfound in the internal database; drug information center notifying thepharmacy validation system of the contents.
 11. (canceled)
 12. A methodas claimed in claim 10, wherein the information includes a shape andcolor the contents.
 13. A method as claimed in claim 10, furthercomprising drug information center sending updates for the internaldatabase in response to the information requests when no match wasfound.